Full Press Release Details
Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update
Revenue increases 4% year over year while
loss from operations decreases by 32%
Pooled Results of ColoFuture and eAArly DETECT
studies published at ASCO showing groundbreaking performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including
95.8% detection of high-grade dysplasia
Company highlights its path to success for
BERKELEY, US - MAINZ, Germany - October 21, 2024 -
Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company
specializing in the early detection of cancer, announced today financial results for the first half
of 2024, an update on 2024 accomplishments, and its outlook for the end of the year and strategic direction for 2025.
Key 2024 Accomplishments
In line with these strategic initiatives, the Company restructured its operations and implemented cost reductions which
included decreasing its operating costs, primarily driven by the reduction of personnel and external consulting costs.
"2024 has been a transitional year for Mainz Biomed. While navigating
through a period of difficult markets, especially for small cap technology stocks, we are proud to have achieved many significant accomplishments
to date," commented Guido Baechler, Chief Executive Officer of Mainz Biomed. "As the Board and management team evaluated our
path forward, we believe that a narrower focus on key strategic initiatives gives us the best opportunity to unlock shareholder value
in the remainder of 2024 and 2025."
Condensed Consolidated Financial Statements (unaudited):
Condensed Consolidated Statements of Profit or Loss and Comprehensive Loss (unaudited)
| Six months ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 520,773 | $ | 499,049 | ||||
| Cost of sales | 201,735 | 211,310 | ||||||
| Product margin | 319,038 | 287,739 | ||||||
| 61 | % | 58 | % | |||||
| Operating expenses: | ||||||||
| Sales and marketing | 2,361,105 | 3,992,975 | ||||||
| Research and development | 3,242,622 | 5,481,229 | ||||||
| General and administrative | 4,522,639 | 5,227,181 | ||||||
| Total operating expenses | 10,126,366 | 14,701,385 | ||||||
| Loss from operations | (9,807,328 | ) | (14,413,646 | ) | ||||
| Other income (expense) | ||||||||
| Other income | 105,851 | 125,968 | ||||||
| Change in fair value of convertible debt | (528,210 | ) | 45,000 | |||||
| Finance expense | - | (250,000 | ) | |||||
| Accretion and interest expense | (659,473 | ) | (88,759 | ) | ||||
| Other expense | (134,602 | ) | (231,206 | ) | ||||
| Total other income (expense) | (1,216,434 | ) | (398,997 | ) | ||||
| Income (loss) before income tax | (11,023,762 | ) | (14,812,643 | ) | ||||
| Income taxes provision | - | - | ||||||
| Net loss | $ | (11,023,762 | ) | $ | (14,812,643 | ) | ||
| Foreign currency translation gain (loss) | (62,366 | ) | (150,596 | ) | ||||
| Comprehensive loss | $ | (11,086,128 | ) | $ | (14,963,239 | ) | ||
| Basic and diluted loss per ordinary share | $ | (0.49 | ) | $ | (1.00 | ) | ||
| Weighted average number of ordinary shares outstanding | 22,350,033 | 14,803,243 |
Condensed Consolidated Financial Statements (unaudited):
Condensed Consolidated Statements of Financial Position
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash | $ | 977,764 | $ | 7,070,925 | ||||
| Trade and other receivables, net | 139,414 | 93,555 | ||||||
| Inventories | 520,531 | 613,638 | ||||||
| Prepaid expenses and other current assets | 751,994 | 1,201,778 | ||||||
| Total Current Assets | 2,389,703 | 8,979,896 | ||||||
| Property and equipment, net | 1,625,373 | 1,702,317 | ||||||
| Intangible assets | 3,206,054 | 3,394,645 | ||||||
| Right-of-use assets | 1,232,900 | 1,332,170 | ||||||
| Other assets | - | |||||||
| Total assets | $ | 8,454,030 | $ | 15,409,028 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 2,903,873 | $ | 3,184,381 | ||||
| Accounts payable and accrued expense - related party | 426,637 | 299,936 | ||||||
| Deferred revenue | 116,679 | 138,889 | ||||||
| Convertible debt | 5,842,003 | 4,903,310 | ||||||
| Convertible debt - related party | 32,140 | 33,118 | ||||||
| Silent partnership | 49,036 | - | ||||||
| Intellectual property acquisition liability - related party | 324,003 | 388,839 | ||||||
| Lease liabilities | 319,573 | 288,463 | ||||||
| Total current liabilities | 10,013,944 | 9,236,936 | ||||||
| Silent partnerships | 713,856 | 758,812 | ||||||
| Silent partnerships - related party | 267,206 | 271,354 | ||||||
| Lease liabilities | 1,046,163 | 1,165,723 | ||||||
| Intellectual property acquisition liability - related party | 551,561 | 726,977 | ||||||
| Total Liabilities | 12,592,730 | 12,159,802 | ||||||
| Shareholders' equity | ||||||||
| Share capital | 276,378 | 235,818 | ||||||
| Share premium | 54,136,785 | 51,507,526 | ||||||
| Reserve | 22,314,598 | 21,286,215 | ||||||
| Accumulated deficit | (80,351,783 | ) | (69,328,021 | ) | ||||
| Accumulated other comprehensive income (loss) | (514,678 | ) | (452,312 | ) | ||||
| Total shareholders' equity | (4,138,700 | ) | 3,249,226 | |||||
| Total liabilities and shareholders' equity | $ | 8,454,030 | $ | 15,409,028 |
Please visit Mainz Biomed's official website for investors
at mainzbiomed.com/investors/ for more information
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About Mainz Biomed NV
Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product
is ColoAlert , a non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer with high sensitivity and specificity.
ColoAlert is marketed in Europe and the United Arab Emirates. The Company is currently preparing a pivotal FDA clinical study for
US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening
test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To
Anne Hennecke/Caroline Bergmann
For investor inquiries, please contact info@mainzbiomed.com
Forward-Looking Statements
Certain statements made in this press release are "forward-looking
statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of words such as "anticipate", "believe", "expect",
"estimate", "plan", "outlook", and "project" and other similar expressions that predict
or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current
analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying
on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations
or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking
statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the
effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein,
as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and
Exchange Commission (the "SEC") by the Company. Additional information concerning these and other factors that may impact
the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form
20-F filed on April 9, 2024. The Company's SEC filings are available publicly on the SEC's website at www.sec.gov. Any forward-looking
statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the
date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral,
that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.